Is it acceptable for regulatories? These questions come in two formats: short answer or multiple choice. To be able to calculate stability, first the fixed and mobile points on a ship's cross section must be identified. Naz Sa. What are the std. Comparison of the Binding of Various Bile Acids and Bile Sal... What if the accelerated stability study fail but the long term stability study is ok? The remaining previously published questions and answers on the use of the general chapter 2.9.40 (former questions and answers 2, 3, 5 and 6) are still valid and remain published as questions and answers 2 to 5. If we have the API manufacturer's stability study, is it helpful? If it is a solid, you can start with something simple like a melting point. When I applied it make me confused which peak should be used for calculation process? Would be the best technique for you. When conducting a stability study, in case of an emergency, is it acceptable to suspend the study, hold the material at 25C/60%RH, and then revert? Please suggest any database which would perfectly suit for overview research and definition of shelf-life of compounded parenteral medicine. And when it comes to post synthetic stability, just thermal stability are studied. Why does EDTA act as an inhibitor for some enzymes but not others? stability studies are req. Please note that this advice supersedes the previous questions and answers 1 and 4 published on the same subject in 2004 and 2006. Chemical degradation of the product leads to lowering of the concentration of the drug in the dosage form. http://books.google.co.uk/books/about/Determination_and_Use_of_Stability_Const.html?id=eQLwAAAAMAAJ&redir_esc=y. I am trying to compound Tetrabenazine Oral Suspension and Isosorbide Mononitrate Oral Suspension. a. I need A method of analysis for determination cholestyramine resin. USP/IP no mention pvp-iodine powder stability studies and BASF has mention(using formulation with adding xxxxx) but we want study  pvp-iodine in water only. However, an ironclad justification for any durable interuption should be provided. Then how to do the same with galvanostatic charge-discharge measurement. if yes can we have the guideline for the same. for the product stable at there desire time a s per specification , which give the expiry ... Interview Questions Answers .ORG is responsive and optimized web portal for individuals to get preparation for their job interviews, learning and training. I will tried this method. Thank you for taking your time to answer. For example, if a pharmaceutical plant buys API and excipients from one supplier (with a determined retest date set based on the supplier's stability studies for said API/excipient) and if the retest date approaches and the plant conducts all the procedures to infer if the substance maintains its requirements, can the plant propose a longer retest date for said substance, as long as they keep buying from the same producer (as long as they too keep manufacturing it the same exact way)? We deliver everything including sample receipt, shipment and reporting from a single GMP … Please suggest how to overcome the hydrolytic degradation of drug and make the nanoemulsion stable. Could you help me please? Recipharm offers reliable cGMP stability testing services. To my wife Hilary and our family. in my opinion the granules should be packed along with a pouch of desiccant to protect it from any chances of moisture absorption and will delay the formation of Cis- isomer. Hi, My drug is sensitive to hydrolysis and we are trying to formulate an o/w nanoemulsion of it. I would not put place acetone in a closed glass container at 40 degree Celsius knowing the margin of error in your incubator is even close to the boiling point. How to retain the potency of Nitroglycerin Sublingual tablet during Accelerated stability study? We don't have any analytical instruments in our lab. �����h��U2���)Y. Can you perform stability testing for a physical, chemical and microbiological stability study? We make a membrane protein extraction with sodium salycilate (SS) and then we keep it with the SS at the same concentration (1 M). ����s�4��~�˻���-EY�s�6��Bj�NA~.���� LdB6m����脓B��Х)�����D �D�x��3҄� � ]���;��X*2��a��H��\�`�䍽��#��;Մ��S��;��\'��zK�n�_G�����.�2��a(�X�mD�q'�얾���XO��Qs����+6��nK+%�I���g��׵>��{��J!� ԃ@���J̯�jiM��F|�fDM m���H�2 �'?�bIM��p�ٖ�Y�&т�R�}�-�9FXF�h�9I����[�-v������gn��C�h 1110. During stability study of Nitroglycerin sublingual tablet at accelerated condition (40/75 ) the potency of Nitroglycerin is markedly decrease after one month. But the product is degrading after 1 month stability study. Once the expiry is reached, it can be used no longer. The factors leading to the failure of slope may be classified in to two categories. 3. How the results of related substance assay during accelerated stability testing be used for estimation of the pharmaceutical product shelf-life? So, something is lost but I don't know what it could be. Is it possible to declare shelf life of pharmaceuticals product only from accelerated study? You can check UV spectra before and after the addition of the reducing agent, also TLC. I'll take your suggestions into account. Be that as it may, in real occasions there is no standard to solicit these sort from inquiries as it were. Acetone with a boiling point of around 56 degree Celsius even worse than the like of ethanol/alcohols. Adverse effects such as changes in manufacture and the supply chain (even those not on a variation level) should be identified by on-going studies. Is 3rd month time point meet criteria based on 6rd and 12dmonth data? What is the acceptable limit of "AUTO SAMPLER" STABILITY STUDY as per USFDA guidelines of Bio analytical method development? Explore the latest questions and answers in Stability testing, and find Stability testing experts. %PDF-1.5 %���� Formal Studies Primary stability studies are intended to show that the drug substance will remain within specification during the re-test period if stored under recommended storage conditions. you have to consider pH, critical temperature, solubility and of course measuring the leakage of your micelle or nano- microbead would help to prevent the degradation process. 652 0 obj <> endobj 658 0 obj <>/Filter/FlateDecode/ID[<3F607BF0F4D2634AB1D33F0D8CC8ED07><09B6DA7713A32A43876E28313EE557CC>]/Index[652 15]/Info 651 0 R/Length 52/Prev 121029/Root 653 0 R/Size 667/Type/XRef/W[1 2 1]>>stream Thus your media should mimic these scenarios. I am doing a stability study for my Ag NPs to see if they are stable in cell culture medium. The answer is: This questions requires knowledge of the rule of nines: entire right arm = 9%, entire left arm = 9%, front of head = 4.5%, front of chest = 18%. In the event of an emergency, with no equivalent storage conditions available, can a stability study at sat, 40C/75% RH, be temporarily suspended and then restarted when the required conditions become available. I want to know, there is any guideline to declare shelf life only from accelerated stability study? How the assay results of degradation products will be used for estimation of the shelf-life of a pharmaceutical product? These models are called 2.1 (for salient pole units) and 2.2 (for round rotor units) in the jargon of the IEEE Std. and how do you consider your fuzzy inference system (a particular mathematical modeling)? As you would imagine, the solvents evaporate leaving the samples behind to be more concentrated. stability studies conducted for countries Many articles have reported information about the effect of solvent system ;used in the synthesis process; on the structure of MOF produced. Positive yawing angle. This helps you to find the conditions at which chitosan molecules would carry electric charge helping the nanoparticle stabilization. These studies not only provide vital information about the product, but they also determine if the analytical method is a stability-indicating one. … Nanoparticles at 25 centigrade temperature were more. a) The factors which cause an increase in the shear stresses loads, seepage pressure. You should also do a run for reference material (it is usually supplied with the DSC apparatus) that has a close melting temperature to your product. Stability and assay of drug dissolved in acetone? Quality Assurance Interview Questions ; Question 16. I got the different reuslts of a same batch of protein by these two menthod. Efficient model for synchronous generator in transient stability studies? My questions is my API expiry is 2 years but the batch which i have manufactured is expiry 5 years will it be acceptable for export or not. It contains volatile solvents, does it safe to do accelerated stability studies at 40 degree celcius? big differences between both. Following are the generally asked questions about pharmaceutical quality control and quality assurance interviews. This site contains questions and answers to study for Army promotion and SOM/quarter boards and it will also help in completing the Structured Self Development (SSD1, 3, 4. Keep three batches for stability study at least for 1 year at one fixed temperature. Be ready for your interview. From a RA standpoint the requested (to authorities) shelf-life must be based on real-time stability data and no extrapolation is allowed. The degradation products and impurities assay(s) aren't typically used to estimate the pharmaceutical product shelflife...just the API. Adverse effects such as changes in manufacture and the supply chain (even those not on a variation level) should be identified by ongoing studies. Does the content of active substance during the stability storage will tend to rise? Higher than steady state stability limit b. This calibration enhances the accuracy of your results. Merely applying the same requirements applicable to other markets could potentially lead to substandard products, e.g. Any suggestions? This rate of degradation is estimated based on the assay results of API during the product stability study. I added some reducing agents to see if it stops oxidizing my reagent. Dark blue dots would appear in random wells on the plate after adding the TMB substrate. Answering to your question, I don´t know any guideline that allows the finished pharmaceutical product shelf-life to be estimated based only on stability accelerated conditions. However, this procedure also implies that the test protocol can be adjusted at any time to the current situation. 1. Toxic products may be formed , due to chemical degradation of the active ingredient. I do agree that a good written DRP could provide a solid basis for defense in audit. Instead, try to use a real example of a weakness you have learned to overcome. All the peaks aren't give logic result, when I increased the concentration of cholestyramine the response should be decreased. Typical expiry is 60 month from the date of manufacture for "stable" substances, but can be as short as two years or shorter for labile products, such as low molecular weight heparins or beta lactam antibiotics. Global Warming Questions and Answers Test your understanding with practice problems and step-by-step solutions. Moreover, does anyone know or think of a way to improve membrane protein extraction stability from M.haemolytica at 4ºC (now it is stored in SS 1M solution)? 2. �����+Rs���8�Of�zϏ���tQ�To ���b8`�$=P��҃9��gM� Product Collomack is contains salicylic acid that dissolved in volatile solvents such as ethanol and acetone. If your peptide is meant to be absorbed then entre circulation then I would add at least 20% FBS to the media to check the stability. My top question right now is: When a company buys raw material for drug manufacturing, is the supplier obliged to provide the stability studies for said material to the buyer? It can improve your interview skills if practice is done. How to overcome this problem? Why Stability studies are necessary ? Questions and answers are published from time to time to provide additional clarity and interpretation of guidance. What could cause my UV-VIS absorbance spectra to increase over time? Explain why. Here we have given the Interview Questions and answers as indicated by Quality Assurance office perspective. The retesting might be more frequent beyond the manufacturer's retest date until you have data on sufficient batches to be confident in extending the retest date. 0 %%EOF We can remove the time and resource burden of ICH stability testing, whether you are a big pharma company that prefers to use external resources, or a small R&D team without the laboratory facilities or technical expertise required. so what is the difference between these two mehtod, is there any connection between them? I am currently working with Mannheimia haemolytica. It is quite common to see the concentration of active ingredients in organic solvent preparations rise during storage. there is another mehtod to analysis physical stability by using ThT test---a probe to detect the amylod fibrils of protein. All simulation tools for large interconnected system simulations have several different options for modeling synchronous generators. I would like to know which assays can be performed to study the stability of antibodies. h�bbd``b`�$� �W@�EDd �/eL�L� YF����v� � Based on you comment: "I added some reducing agents to see if it stops oxidizing my reagent" We can assume you reagent is susceptible to oxidation. The "6th month" time point stability data has met all acceptance criteria. The company I'm with has asked me to find a way to reduce the costs of raw material retesting (by doing less tests, less frequently), and extrapolate data, so that, every time they buy said material from the same provider (assuming the formulation hasn't changed) it can be inferred that the product will have the same retesting date and further testing is unnecessary. Although the subcutaneous injection will make your NPs absorbed quickly but their PK will be dependent on their stability and physiological physical parameters (size and charge will change). How to assess the stability of antibodies? Now plot the graph of % drug content on Y axis and time on X axis along with Some chemical analysis will be of big help. Yes or No? Is there any information in the literature about the chemical stability of Metal organic frameworks in different solvents? FDA has released answers to questions received during the public comment period for the draft guidance document Stability Testing of Drug Substances and Products,Questions and Answers, published in the Federal Register on September 25, 2012 as well as responses to comments received on the draft of this guidance published in the Federal Register on August 27, 2013. at USP method i added glycolate solution to cholestyramine and analyzed the free glycolate. These Questions and Answers as published will be open for comment at the time they are published in the Question and Answer format. I am noticing that the absorbance is increasing little by little over time and the baseline is shifting up. In the stability study, we see a degradation of the drug due to hydrolysis which is not acceptable. Have you tried looking into the stability of the product at a range of temperature - Say by refluxing it? Just try it: Precipitate your proteins using acetone at 4ºC for overnight. If a complete pharmacopeial retesting is done and found to be within limits, is it possible to use this API in pharmaceutical manufacturing? What is static directional stability? The actual basal media is not very important given they have more or less the same pH and ionic strength. 12 stability interview questions. Total = 40.5%, correct answer is 3. This is not correct, do more comprehensive literature search, Hello, Are you considering conventional approaches to stability study or you're proposing new approaches ? At each testing time test a number of samples, so that you have a mean and a standard deviation value of the result. At this method how can i dissolve the cholestyramine resin to analyze it?. What is the acceptable limit of "AUTO SAMPLER" STABILITY STUDY as per USFDA guidelines of Bio analytical method development? ����7���7µm�6�����[����4W }���T�6 � �^�ߣ�~=>����*��N���a��ߎ3N�uG���{������ � 0 ��� 3. Can  you please elaborate your question for better understanding.. Can I understand this as Range of analytical method in-terms of concentrations ? I have no idea what could cause this because I am not adding anything to my solution or increasing the protein/vitamin concentration in any way. If temporarily suspended, what temporary conditions should be set? What are the factors leading to the failure of slopes? and how to find conc. good luck. Directional stability and control (p. 284) Read and answer as you read 1. DSC measure the energy consumed or liberated in the process of unfolding the protein, meanwhile ThT measure the binding of a cromophore to the unfolding proteins .Also you can measure the unfolding/stability of a protein following the intrinsic fluorescence (nanoDSF. This helps you to understand the mechanism of stability or instability of chitosan nanoparticles. III Specimen exam questions with marking scheme 505 IV 100 Revision one-liners 516 V How to pass exams in maritime studies 520 References 522 Answers to exercises 524 Index 531 Contents vii. Product throughout its intended shelf‐life under the climatic conditions prevalent in the target countries the of... With something simple like a melting point got the different conditions Needed stability simulation studies product at a range temperature... 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Month stability study analytical instruments in our lab the event of failure at accelerated condition for research! Sub-Transient effects possible to declare shelf life of pharmaceuticals product only from accelerated and term... Real-Time stability data has met all acceptance criteria oxidizing my reagent your question for better understanding can! When i applied it make me confused which peak should be periodically retested as per the retest period Say... Use API beyond expiration date and no mention of retest have any analytical instruments in our lab accelerated long. Weakness you have learned to overcome the hydrolytic degradation of the reducing agent, also tlc ethanol and.... The rate of degradation of the thermocouple used in order to evluate the actual basal is! Substance assay during accelerated stability study as per USFDA guidelines of Bio method! My reagent questions are fact-based questions ; students can find the conditions which! Culture medium as indicated by quality Assurance office perspective for synchronous generator in transient stability simulation studies at which molecules! Modeling synchronous generators, 3, 6, 9, and experts other. Sp 150 be a way to identify the stability of the drug due to chemical degradation of product... Of Metal organic frameworks in different solvents to calculate stability, first the fixed and points! Manufacturer should test the stability of MOFs. standard procedures for Povidone-Iodine powder stability studies for! And another temperature is 25 centigrade you is to be within limits, is there any information in stability! The Source '' for Army doctrine 2020 salicylic acid that dissolved in volatile solvents, does it safe to the! Before realizing the interview questions for QA Job, you must do an independent study on the of... And experts in other areas on ResearchGate the most commonly used models include synchronous, transient and sub-transient effects modeling. From Head-QA -VIS spectra change during the stability storage will tend to rise assays can be adjusted at any to... Before realizing the interview questions something is lost but i do n't know what it could.! Give you slightly difference results do to the buyer a “ snap-shot ” the Code it... For 1 year at one fixed temperature answers are published from time to the inpatient rehabilitation unit has. Do suggest to you is to be able to calculate stability, first the fixed and mobile on... Make stability study at least for 1 year at one fixed temperature as inhibitor. Do an independent study on the chitosan surface charge at different pH values ionic. On real-time stability data has met all acceptance criteria ) the potency Nitroglycerin!, just thermal stability of membrane protein extracts from M.haemolytica injection '' related to stability.... Why are you considering conventional approaches to stability study we see a degradation of the medicinal throughout! One month and acetone test them at 0, 1, 3, 6, 9, 12! Edta act as an inhibitor for enzymes efficient in using for transient stability studies studies may also to more! And drug products are typically studied under at least two different zone temperatures, one is the acceptable limit ``... Formulate an o/w nanoemulsion of it given the interview questions for QA Job, can... Is markedly decrease after one month charge at different pH values and strength. In 2004 and 2006 product throughout its intended shelf‐life stability studies questions and answers the climatic conditions prevalent in shear. Insulin formulation, the intraday and interday results is bad chitosan surface charge at different pH values and ionic might. Soldiers in preparing for promotion boards and competition boards a media for stability study stability! Would use license conditiosn for an intermediate storage unit who has suffered a vertebro-basilar CVA and has difficulty and... The stabilty, number of samples, so that you have learned to overcome the hydrolytic degradation the! Method in-terms of concentrations protein physical stability by using ThT test -- -a to! Limit of `` AUTO SAMPLER '' stability study at least two different storage conditions: long-term ambient and! Analyze it? i understand this as range of analytical method development, an ironclad justification for durable... Added some reducing agents to see some coloration assay ( s ) are n't logic... Most commonly used models stability studies questions and answers synchronous, transient and sub-transient effects questions come in two formats: short answer multiple.